AVANOS MEDICAL INC. HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR
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Model Number C270050 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
Event Type
malfunction
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Event Description
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Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 2026095-2024-00006 for the second report.Refer to 2026095-2024-00007 for the third report.Fill volume: 243 ml.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.Infusion start time: (b)(6) 2024 4:20 pm.Infusion stop time: unknown.It was reported, patient with arthroscopic knee ligament reconstruction surgery, had a pump installed on (b)(6) 2023 at 4:20 pm for pain control.The pump was intended to infuse for five days.On day four of treatment, at 10:10 pm, the pump had very little volume.There was still approximately 18 hours left for the infusion.No injury or medical interventions reported.
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 11 jan 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Manufacturer Narrative
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The device history record for lot 30200983 was reviewed and the product was produced according to product specifications.A root cause could not be determined.All information reasonably known as of 26 mar 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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